TICAGRELOR 60 mg Film-Coated Tablets

Зміст інструкції

1. Ticagrelor Abdi 60 mg film-coated tablets
   1. What is Ticagrelor Abdi and what it is used for
   2. What you need to know before taking Ticagrelor Abdi
   3. How to take Ticagrelor Abdi
   4. Possible side effects
   5. How to store Ticagrelor Abdi
   6. Package Contents and Other Information
2. Ticagrelor Abdi 90 mg film-coated tablets
   1. What is Ticagrelor Abdi and what it is used for
   2. What you need to know before taking Ticagrelor Abdi
   3. How to take Ticagrelor Abdi
   4. Possible side effects
   5. How to store Ticagrelor Abdi
   6. Package contents and other information

Ticagrelor Abdi 60 mg film-coated tablets

ticagrelor

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Ticagrelor Abdi is and what it is used for
• 2. What you need to know before you take Ticagrelor Abdi
• 3. How to take Ticagrelor Abdi
• 4. Possible side effects
• 5. How to store Ticagrelor Abdi
• 6. Contents of the pack and other information

1. What is Ticagrelor Abdi and what it is used for

What is Ticagrelor Abdi
Ticagrelor Abdi contains an active ingredient called ticagrelor. This belongs to a group of
medicines called antiplatelet agents.

What is Ticagrelor Abdi used for
Ticagrelor Abdi in association with acetylsalicylic acid (another antiplatelet agent) must
be used only in adult patients. This medicine has been prescribed to you because you have had:

• a heart attack more than a year ago. This medicine reduces the chances that you will have another heart attack or stroke or that you may die from a disease related to heart or blood vessel problems.

How Ticagrelor Abdi works
Ticagrelor Abdi acts on cells called “platelets” (also called thrombocytes). These are very
small blood cells that help to stop bleeding by clumping together to close the
tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels of the heart and
brain. This can be very dangerous, because:

• the clot can completely interrupt the blood supply; this can cause a heart attack (myocardial infarction) or stroke, or:
• the clot can partially block the blood vessels that supply the heart; this reduces blood flow to the heart and can cause chest pain that comes and goes (called “unstable angina”). Ticagrelor Abdi helps to block the aggregation of platelets. This reduces the possibility of a blood clot forming that can reduce blood flow.

2. What you need to know before taking Ticagrelor Abdi

Do not take Ticagrelor Abdi if:

• you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• You have active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You suffer from severe liver problems.
• You are taking any of the following medicines:
• ketoconazole (used for the treatment of fungal infections)
• clarithromycin (used for the treatment of bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV infection and AIDS) Do not take Ticagrelor Abdi if any of the above situations apply to you. If you are not sure, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ticagrelor Abdi if:

• You have an increased risk of bleeding due to:
• a recent serious injury
• a recent surgery (including dental surgery, ask your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (e.g., due to a stomach ulcer or “polyps” in the colon).
• You are planning to have surgery (including dental surgery) at any time during your treatment with Ticagrelor Abdi. This is because there is an increased risk of bleeding. Your doctor may advise you to stop taking this medicine 5 days before your surgery.
• Your heart rate is unusually slow (typically less than 60 beats per minute) and you do not already have a device implanted that regulates your heart rhythm (pacemaker).
• You suffer from asthma or other lung problems or have difficulty breathing.
• You develop irregular breathing patterns such as acceleration, slowing down or brief pauses in breathing. The doctor will decide if further evaluation is necessary.
• You have already had problems with your liver or have previously had any condition that has affected your liver.
• You have already had blood tests showing a higher than normal amount of uric acid. If any of the above situations apply to you (or if you are not sure), talk to your doctor or pharmacist before taking this medicine.

If you are taking both Ticagrelor Abdi and heparin:

• The doctor may request a blood sample for diagnostic tests if they suspect a rare platelet disease caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Abdi and heparin, as Ticagrelor Abdi may affect the diagnostic test.

Children and adolescents
Ticagrelor Abdi is not recommended in children and adolescents under 18 years of age.

Other medicines and Ticagrelor Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Ticagrelor Abdi can affect the way some
medicines work, and some medicines can have an effect on Ticagrelor Abdi.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine for treating high cholesterol)
• more than 40 mg per day of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to lower the body's defenses)
• quinidine and diltiazem (used in the treatment of abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
increase the risk of bleeding:

• “oral anticoagulants” often referred to as ‘blood thinners’, including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs), often used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (abbreviated as SSRIs) taken as antidepressants, such as paroxetine, sertraline and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used for the treatment of migraine and headache). Also, inform your doctor that, because you are taking Ticagrelor Abdi, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called ‘thrombolytics’, such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Ticagrelor Abdi is not recommended if you are pregnant or suspect you may be pregnant. Women must use appropriate contraceptive methods to avoid pregnancy while taking
this medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. The doctor
will discuss with you the benefits and risks of treatment with Ticagrelor Abdi during this period.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Abdi will affect your ability to drive or operate
machinery. If you experience dizziness or confusion while taking this medicine, be careful
while driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take Ticagrelor Abdi

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much Ticagrelor Abdi to take

• The usual dose is one 60 mg tablet twice a day. Continue to take Ticagrelor Abdi for the entire period indicated by your doctor.
• Take this medicine at about the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Abdi with other medicines for blood coagulation
Your doctor will generally tell you to also take acetylsalicylic acid. This is a substance present in
many medicines used to prevent blood clotting. Your doctor will tell you how much to take
(usually between 75 and 150 mg per day).

How to take Ticagrelor Abdi

• You can take the tablet with or without food.
• You can check when you took your last Ticagrelor Abdi tablet by looking at the blister. There is a sun (for the morning) and a moon (for the evening). This will tell you if you have taken the dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To make sure you have not left any medicine, rinse the empty glass with another half glass of water and drink. If you are in hospital, the tablet can be given to you mixed with some water and administered with a tube through your nose (nasogastric tube).

If you take more Ticagrelor Abdi than you should
If you take more Ticagrelor than you should, contact your doctor or go to hospital immediately.
Bring the medicine packaging with you. You may be at increased risk of bleeding.

If you forget to take Ticagrelor Abdi

• If you forget to take a dose, take the next dose as usual.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Ticagrelor Abdi
Do not stop taking Ticagrelor Abdi without first talking to your doctor. Take this medicine
regularly and until your doctor prescribes it. If you stop taking Ticagrelor Abdi,
this may increase your chances of having another heart attack or stroke, or that you may die from
a disease related to heart or blood vessel problems.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Ticagrelor Abdi affects blood clotting, therefore many side effects are related to
bleeding. Bleeding can occur in any part of the body. Some bleeding is
common (such as bruises and nosebleeds). Severe bleeding is uncommon, but
can be life-threatening.

Seek immediate medical attention if you notice any of the following symptoms – you may need
urgent medical care:

• Bleeding in the brain or inside the skull is an uncommon side effect andcan cause signs of a stroke, such as:
• sudden numbness or weakness of arms, legs or face, especially if only on one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking or loss of balance or coordination
• sudden dizziness or sudden and severe headache with no known cause
• Signs of bleeding, such as:
• severe bleeding or that cannot be stopped
• unexpected bleeding or bleeding that lasts a long time
• pink, red or brown urine
• vomiting red blood or your vomit looks like coffee grounds
• red or black stools (appear tarry)
• coughing up or vomiting blood clots
• Fainting (syncope):
• a temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
• Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP), such as:
• fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion.

Contact your doctor if you notice any of the following symptoms:

• Feeling of shortness of breath- this event is very common. It may be due to your heart condition or another cause, or it could be a side effect of Ticagrelor Abdi. Dyspnea (shortness of breath) due to Ticagrelor Abdi is generally mild and characterized by a sudden, unexpected need for air that usually occurs at rest and can occur in the first weeks of therapy and may disappear for many. If your feeling of shortness of breath worsens or persists, tell your doctor. The doctor will decide whether treatment is necessary or to proceed with further investigations.

Other side effects
Very common (may affect more than 1 in 10 people)

• High uric acid concentration in the blood (as shown by tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or as if the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Skin rash
• Itching
• Severe pain and swelling of the joints - these are signs of gout
• Feeling dizzy or confused, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding following surgery or from cuts (for example during shaving) and wounds, more than normal
• Bleeding of the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - skin rash, itching, or swelling of the face or lips/tongue can be signs of an allergic reaction
• Confusion
• Vision problems caused by blood in the eyes
• Heavier vaginal bleeding or that occurs at times other than normal menstrual bleeding
• Bleeding in the joints and muscles that can cause painful swelling
• Blood in the ears
• Internal bleeding, this can cause dizziness or confusion

Reporting of side effects
If you get any side effects, talk to your
doctor. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Ticagrelor Abdi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
”Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ticagrelor Abdi Contains

• The active ingredient is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet Core: mannitol (E421), dihydrate calcium hydrogen phosphate, sodium croscarmellose, hydroxypropylcellulose (E463), ethanol (96%), granulated mannitol, anhydrous colloidal silica, magnesium stearate (E470b)

Tablet Coating: HPMC2910/hypromellose (E464), titanium dioxide (E171), iron oxide black/ferric oxide black (E172), macrogol (PEG), iron oxide yellow (E172), iron oxide red (E172), talc.

Description of Ticagrelor Abdi and Package Contents
Film-coated tablet (tablet): the tablets are round, biconvex, light pink in color, film-coated, with imprinted “ ” on one side and smooth on the other.
Ticagrelor Abdi is available in:

• blisters in packs of 14, 56, 60 and 168 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Flavine Pharma France
3 Voie d´Allemagne
13127 Vitrolles
France
Pharmadox Healthcare Ltd.

• 1. KW20A Kordin Industrial Park, Paola PLA3000, 2. Warehouse No.1 and No.2, Hal Farrug Road, Luqa LQA9040,

Malta

Ticagrelor Abdi 90 mg film-coated tablets

ticagrelor

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 7. What Ticagrelor Abdi is and what it is used for
• 8. What you need to know before you take Ticagrelor Abdi
• 9. How to take Ticagrelor Abdi
• 10. Possible side effects
• 11. How to store Ticagrelor Abdi
• 12. Contents of the pack and other information

7. What is Ticagrelor Abdi and what it is used for

What is Ticagrelor Abdi
Ticagrelor Abdi contains an active substance called ticagrelor, which belongs to a group of medicines
called antiplatelet agents.

What is Ticagrelor Abdi used for
Ticagrelor Abdi in combination with acetylsalicylic acid (another antiplatelet agent) must
be used only in adult patients. This medicine has been prescribed for you because you have had:

• a heart attack or
• unstable angina (angina or chest pain that is not well controlled). This medicine reduces the chances of you having another heart attack or stroke or dying from a condition related to heart or blood vessel problems.

How Ticagrelor Abdi works
Ticagrelor Abdi works on cells called “platelets” (also called thrombocytes). These are very
small cells in the blood that help to stop bleeding by clumping together to close the
tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside the diseased blood vessels of the heart and
brain. This can be very dangerous, because:

• the clot can completely interrupt the blood supply; this can cause a heart attack (myocardial infarction) or stroke, or:
• the clot can partially block the blood vessels that supply the heart; this reduces the blood flow to the heart and can cause chest pain that comes and goes (called “unstable angina”).

Ticagrelor Abdi helps to block the clumping together of platelets. This reduces the possibility of a blood
clot forming that can reduce blood flow.

8. What you need to know before taking Ticagrelor Abdi

Do not take Ticagrelor Abdi if:

• you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• You have active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You suffer from severe liver problems.
• You are taking any of the following medicines:
• ketoconazole (used for the treatment of fungal infections)
• clarithromycin (used for the treatment of bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV infection and AIDS) Do not take Ticagrelor Abdi if any of the above situations apply to you. If you are not sure, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ticagrelor Abdi if:

• You have an increased risk of bleeding due to:
• a recent serious injury
• a recent surgical procedure (including dental surgery, ask your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (e.g., due to a stomach ulcer or “polyps” in the colon).
• You are planning to have a surgical procedure (including dental surgery) at any time during your treatment with Ticagrelor Abdi. This is because there is an increased risk of bleeding. Your doctor may advise you to stop taking this medicine 5 days before the surgery.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted that regulates your heart rhythm (pacemaker).
• You suffer from asthma or other lung problems or have difficulty breathing.
• You develop irregular breathing patterns such as acceleration, slowing down or brief pauses in breathing. Your doctor will decide if further evaluation is necessary.
• You have already had problems with your liver or have previously had any condition that has affected your liver.
• You have already had blood tests showing a higher than normal amount of uric acid. If any of the above situations apply to you (or if you are not sure), talk to your doctor or pharmacist before taking this medicine.

If you are taking both Ticagrelor Abdi and heparin:

• Your doctor may request a blood sample for diagnostic tests if they suspect a rare platelet disease caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Abdi and heparin, as Ticagrelor Abdi may affect the diagnostic test.

Children and adolescents
Ticagrelor Abdi is not recommended in children and adolescents under 18 years of age.

Other medicines and Ticagrelor Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Ticagrelor Abdi can affect the way some
medicines work, and some medicines can have an effect on Ticagrelor Abdi.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine for treating high cholesterol)
• more than 40 mg per day of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to lower the body's defenses)
• quinidine and diltiazem (used in the treatment of abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain).

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
increase the risk of bleeding:

• “oral anticoagulants” often referred to as ‘blood thinners’, including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs), often used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (abbreviated as SSRIs) taken as antidepressants, such as paroxetine, sertraline and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used for the treatment of migraine and headache). Also, tell your doctor that, because you are taking Ticagrelor Abdi, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called ‘thrombolytics’, such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Ticagrelor Abdi is not recommended if you are pregnant or suspect you may be pregnant. Women
must use appropriate contraceptive methods to avoid pregnancy during treatment with
this medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. The doctor
will discuss with you the benefits and risks of treatment with Ticagrelor Abdi during this period.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Abdi will affect your ability to drive vehicles or use
machinery. If you experience dizziness or confusion while taking this medicine, be careful
while driving or using machines.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

9. How to take Ticagrelor Abdi

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

How much Ticagrelor Abdi to take

• The initial dose is two tablets at once (loading dose of 180 mg). This dose will normally be given to you in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you otherwise.
• Take this medicine at about the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Abdi with other medicines for blood clotting
Your doctor will generally tell you to also take acetylsalicylic acid. This is a substance present in
many medicines used to prevent blood clotting. Your doctor will tell you how much to take
(usually between 75 and 150 mg per day).

How to take Ticagrelor Abdi

• You can take the tablet with or without food.
• You can check when you took your last Ticagrelor Abdi tablet by looking at the blister. There is a sun (for the morning) and a moon (for the evening). This will tell you if you have taken the dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To make sure you have not left any medicine, rinse the empty glass with another half glass of water and drink. If you are in hospital, the tablet can be given to you mixed with a little water and administered with a tube through your nose (nasogastric tube).

If you take more Ticagrelor Abdi than you should
If you take more Ticagrelor Abdi than you should, contact your doctor or go to hospital
immediately. Bring the medicine packaging with you. You may be at increased risk of
bleeding.

If you forget to take Ticagrelor Abdi

• If you forget to take a dose, take the next dose as usual.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Ticagrelor Abdi
Do not stop taking Ticagrelor Abdi without first talking to your doctor. Take this medicine
regularly and until your doctor prescribes it. If you stop taking Ticagrelor Abdi,
this may increase your chances of having another heart attack or stroke, or of dying from
a disease related to heart or blood vessel problems.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine:
Ticagrelor Abdi affects blood coagulation, therefore many side effects are related to
bleeding. Bleeding can occur in any part of the body. Some bleeding is
common (such as bruises and nosebleeds). Severe bleeding is uncommon, but
can be life-threatening.

Contact a doctor immediately if you notice any of the following symptoms – you may need
urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect andcan cause signs of a stroke, such as:
• sudden numbness or weakness of arms, legs or face, especially if only on one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking or loss of balance or coordination
• sudden dizziness or sudden and severe headache with no known cause
• Signs of bleeding, such as:
• severe bleeding or that cannot be controlled
• unexpected bleeding or bleeding that lasts a long time
• urine that is pink, red, or brown
• vomiting red blood or your vomit looks like coffee grounds
• stools that are red or black (appear tarry)
• coughing up or vomiting blood clots
• Fainting (syncope):
• a temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
• Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP), such as:
• fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion

Contact your doctor if you notice any of the following symptoms:

• Feeling short of breath- this event is very common. It may be due to your heart condition or another cause, or it may be a side effect of Ticagrelor Abdi. Dyspnea (shortness of breath) due to Ticagrelor Abdi is generally mild and characterized by a sudden, unexpected need for air that generally occurs at rest and can

manifest in the first weeks of therapy and may disappear for many. If your feeling of
shortness of breath worsens or persists over time, tell your doctor. The doctor will decide if
treatment is necessary or proceed with further investigations.

Other side effects
Very common (may affect more than 1 in 10 people)

• High uric acid concentration in the blood (as shown by tests)
• Bleeding caused by blood diseases

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or as if the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Skin rash
• Itching
• Severe pain and swelling of the joints - these are signs of gout
• Feeling dizzy or confused, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding following surgery or from cuts (for example during shaving) and wounds, more abundant than normal
• Bleeding from the stomach wall (ulcer)
• Gum bleeding

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - skin rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by blood in the eyes
• Heavier vaginal bleeding or that occurs at times other than normal menstrual bleeding
• Bleeding in the joints and muscles that can cause painful swelling
• Blood in the ears
• Internal bleeding, this can cause dizziness or confusion

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

11. How to store Ticagrelor Abdi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after
”Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Ticagrelor Abdi contains

• The active ingredient is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol (E421), dihydrate calcium hydrogen phosphate, sodium croscarmellose, hydroxypropylcellulose (E463), ethanol (96%), granulated mannitol, anhydrous colloidal silica, magnesium stearate (E470b).

Tablet coating: HPMC2910/hypromellose (E464), titanium dioxide (E171), macrogol
(PEG), yellow iron oxide (E172), talc.

Description of the appearance of Ticagrelor Abdi and package contents
Film-coated tablet (tablet): the tablets are round, biconvex, light yellow in color,
film-coated, with imprinted “ ” on one side and smooth on the other.
Ticagrelor Abdi is available in:

• blisters in packs of 14, 56, 60, 100 and 168 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Flavine Pharma France
3 Voie d´Allemagne
13127 Vitrolles
France
Pharmadox Healthcare Ltd.

• 1. KW20A Kordin Industrial Park, Paola PLA3000, 2. Warehouse No.1 and No.2, Hal Farrug Road, Luqa LQA9040, Malta